Nonpharmacologic Treatment for Surgery

(VERITAS Trial)

Overseen By Karthik Raghunathan, MD MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Durham VA Medical Center

Disqualifiers: Hearing loss, Risk of bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of non-drug treatments like music therapy, aromatherapy, and battlefield acupuncture (a form of ear acupuncture) in alleviating pain and anxiety after surgery. Researchers aim to determine if these treatments can reduce the need for pain medications. Participants will receive either one of these therapies along with their usual care or just the standard care alone. The trial seeks veterans scheduled for surgery at the Durham VA, excluding those with hearing loss, ear procedures, risk of bleeding, or a loss of smell. As a Phase 4 trial, this research explores how these FDA-approved treatments can benefit more patients.

Do I need to stop taking my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications.

What is the safety track record for these treatments?

Research shows that the treatments under study—Music Medicine, Aromatherapy, and Battlefield Acupuncture—are generally safe for people.

Studies have found that Music Medicine greatly reduces pain and anxiety during and after surgery. It is a safe, non-invasive, and affordable way to aid recovery.

Aromatherapy, using oils like ginger, lavender, and peppermint, has proven effective in easing nausea and reducing pain after surgery. The American Society of Anesthesiologists considers it safe.

Battlefield Acupuncture is safe and well-tolerated for managing sudden pain. It is easy to use, low-cost, and has few side effects.

Overall, these treatments have received positive feedback in past studies, making them a promising option for managing pain and anxiety without relying on medication. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they offer nonpharmacologic alternatives for managing surgical recovery. Music Medicine uses the power of sound to help reduce stress and promote healing, Aromatherapy employs essential oils to enhance emotional well-being, and Battlefield Acupuncture targets specific ear points to quickly alleviate pain. Unlike traditional postoperative care that often relies on medications, these integrative treatments have the potential to minimize drug-related side effects while enhancing patient comfort and recovery.

What evidence suggests that these integrative treatments are effective for managing perioperative pain and anxiety?

This trial will compare integrative treatments with standard care for surgery recovery. Research has shown that music therapy, one of the integrative treatments participants may receive, can greatly reduce pain and anxiety after surgery. Studies have found that listening to music can lower pain levels and heart rate, aiding faster recovery. Aromatherapy, another treatment option in this trial, uses lavender and peppermint oils and has been effective in managing pain and nausea after surgery. It can significantly reduce pain within a few days. Battlefield Acupuncture, the third treatment option under study, is a type of ear acupuncture that has successfully reduced pain after surgery, especially when combined with regular medical care. These non-drug treatments may help reduce the need for pain medications. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for veterans scheduled for surgery at the Durham VA who do not have hearing loss, ear procedures, a risk of bleeding, or anosmia (loss of smell). It's designed to help those dealing with joint pain from injuries and issues related to anesthesia and knee osteoarthritis.

Inclusion Criteria

Veterans scheduled to undergo procedures at the Durham VA

Exclusion Criteria

History of hearing loss

I have had procedures done on my ear.

I cannot smell anything.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Assessment of heart rate variability and implementation measures among patients and providers

5 days

Daily assessments

Treatment

Participants receive integrative treatments such as Music Medicine, Aromatherapy, and Battlefield Acupuncture, or standard care

5 days

Daily treatments and assessments

Follow-up

Participants are monitored for pain, opioid use, and quality of recovery

5 days

Daily assessments

What Are the Treatments Tested in This Trial?

Interventions

• Music Medicine, Aromatherapy, Battlefield Acupuncture

Trial Overview The study tests non-drug treatments like Music Medicine, Aromatherapy, and Battlefield Acupuncture against standard care. The goal is to see if these can better manage pain and anxiety around the time of surgery while reducing the need for medications.

How Is the Trial Designed?

Group I: Integrative Treatment Active Control 1 Intervention

200 participants will receive at least one of three integrative treatments: Music Medicine, Aromatherapy, Battlefield Acupuncture

Group II: Standard Care Active Control 1 Intervention

200 patients will not receive standard care without any additional integrative treatments

Who Is Running the Clinical Trial?

Durham VA Medical Center

Lead Sponsor

Trials

40

Recruited

9,300+

Published Research Related to This Trial

Perioperative music therapy significantly reduces postoperative pain and anxiety, with a large effect size observed in a meta-analysis of 19 randomized controlled trials involving 1803 patients.

The therapy also helps stabilize vital signs, leading to lower blood pressure and heart rate on the first postoperative day, although it does not improve hospital satisfaction or reduce nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Perioperative Music Therapy on Patients with Postoperative Pain and Anxiety: A Systematic Review and Meta-Analysis. Li, G., Yu, L., Yang, Y., et al.[2023]

Music therapy, which has been used since ancient times and incorporated into modern medicine since the 1950s, is now a common practice in cancer care, particularly in large cancer centers in the U.S.

When combined with conventional cancer treatments, music therapy has been shown to improve patients' quality of life, enhance emotional expression, reduce stress, and alleviate physical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in a comprehensive cancer center. Richardson, MM., Babiak-Vazquez, AE., Frenkel, MA.[2008]

Music therapy is an effective complementary treatment for cancer patients, helping to improve mood, reduce stress, pain, and anxiety, and enhance relaxation during their treatment process.

Integrating music therapy into supportive cancer care can significantly promote overall wellness and improve both physical and emotional well-being, contributing to a better quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in supportive cancer care. Stanczyk, MM.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11236078/

Aromatherapy for the prevention of postoperative nausea ... Subgroup analysis indicated that ginger essence, lavender, and peppermint oils were particularly effective in managing postoperative nausea.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876382023000653

Effect of aromatherapy on postoperative pain relief The addition of aromatherapy to routine care significantly reduced postoperative pain. •. Aromatherapy did not significantly reduce anxiety levels. •. Certainty ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5192342/

The Effectiveness of Aromatherapy in Reducing Pain Based on the available research, aromatherapy is most effective in treating postoperative pain (SMD = −1.79, 95% CI: −2.08, −1.51, p < 0.0001) and obstetrical ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/15/9/e099639

a systematic review and meta-analysis protocol Introduction Acute pain in the postoperative period of cardiac surgery is mostly treated with opioid analgesics. However, with the risk of adverse reactions ...

5. painmanagementnursing.org painmanagementnursing.org/article/S1524-9042(25)00132-8/fulltext

Inhalation Aromatherapy With Lavender for Postoperative ... Lavender aromatherapy reduced the pain score of patients from 5.43 ± 2.81 before intervention to 1.04 ± 1.825 on the third day after surgery. There was a ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1524904225001328

Inhalation Aromatherapy With Lavender for Postoperative ... Inhaled lavender aromatherapy significantly reduced postoperative pain in adults. However, evidence is insufficient to confirm its effect on reducing analgesic ...

7. myamericannurse.com myamericannurse.com/aromatherapy-compliance-in-the-post-anesthesia-care-unit/

Aromatherapy Compliance in the Post-Anesthesia Care Unit Results from this project suggest that the effectiveness of aromatherapy on PONV symptoms remains inconclusive. However, the findings underscore ...

8. blog.beekley.com blog.beekley.com/clinical-aromatherapy-and-post-surgical-pain-management

Clinical Aromatherapy and Post-Surgical Pain Management The American Society of Anesthesiologists lists aromatherapy as a safe and effective alternative for managing pain post-surgery.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06833658

Effects of Aromatherapy with Essential Oils on Anxiety and ... The objective of this study is to investigate whether aromatherapy essential oils are effective in alleviating anxiety and depression in participants ...